Relmada Therapeutics Appoints Renowned Urologic Oncologist, Yair Lotan, MD, to Chair the Clinical Advisory Board and Support Development of NDV-01
Relmada Therapeutics (NASDAQ:RLMD) has appointed renowned urologic oncologist Dr. Yair Lotan as Chair of its Clinical Advisory Board (CAB). Dr. Lotan, with over 20 years of experience in bladder cancer care and clinical development, will support the advancement of NDV-01, the company's treatment for non-muscle invasive bladder cancer (NMIBC).
The appointment comes as Relmada prepares to initiate a Phase 3 trial for NDV-01 in H1 2026, following positive Phase 2 data presented at AUA 2025. NDV-01's ready-to-use sustained release formulation aims to improve upon the current gemcitabine/docetaxel combination treatment by offering easier administration outside hospital settings.
Relmada Therapeutics (NASDAQ:RLMD) ha nominato il rinomato oncologo urologico Dr. Yair Lotan come Presidente del suo Clinical Advisory Board (CAB). Il Dr. Lotan, con oltre 20 anni di esperienza nella cura del cancro alla vescica e nello sviluppo clinico, supporterà l'avanzamento di NDV-01, il trattamento dell'azienda per il carcinoma della vescica non muscolo-invasivo (NMIBC).
La nomina arriva mentre Relmada si prepara a iniziare una fase 3 dello studio su NDV-01 nella prima metà del 2026, a seguito dei dati positivi della fase 2 presentati all'AUA 2025. La formulazione pronta all'uso a rilascio prolungato di NDV-01 mira a migliorare il trattamento attuale a base di gemcitabina/docetaxel offrendo una somministrazione più semplice anche al di fuori degli ospedali.
Relmada Therapeutics (NASDAQ:RLMD) ha nombrado al reconocido oncólogo urológico Dr. Yair Lotan como presidente de su Consejo Asesor Clínico (CAB). El Dr. Lotan, con más de 20 años de experiencia en el cuidado del cáncer de vejiga y desarrollo clínico, apoyará el avance de NDV-01, el tratamiento de la compañía para el cáncer de vejiga no músculo invasivo (NMIBC).
El nombramiento se produce mientras Relmada se prepara para iniciar un ensayo de Fase 3 para NDV-01 en el primer semestre de 2026, tras datos positivos de la Fase 2 presentados en AUA 2025. La formulación lista para usar de liberación sostenida de NDV-01 busca mejorar el tratamiento actual con combinación de gemcitabina/docetaxel ofreciendo una administración más sencilla fuera del entorno hospitalario.
Relmada Therapeutics (NASDAQ:RLMD)는 저명한 비뇨기 종양학자 Dr. Yair Lotan을 임상 자문 위원회(CAB) 의장으로 임명했습니다. 방광암 치료 및 임상 개발 분야에서 20년 이상의 경험을 가진 Dr. Lotan은 비근육침습성 방광암(NMIBC) 치료제인 NDV-01의 개발을 지원할 예정입니다.
이번 임명은 Relmada가 2026년 상반기에 NDV-01의 3상 임상시험을 시작할 준비를 하는 가운데 이루어졌으며, 2025년 AUA에서 발표된 긍정적인 2상 데이터에 따른 조치입니다. NDV-01의 즉시 사용 가능한 지속 방출 제형은 현재의 젬시타빈/독세탁셀 병용 치료를 개선하여 병원 외에서도 더 쉽게 투여할 수 있도록 설계되었습니다.
Relmada Therapeutics (NASDAQ:RLMD) a nommé le célèbre oncologue urologue Dr. Yair Lotan président de son comité consultatif clinique (CAB). Le Dr Lotan, fort de plus de 20 ans d'expérience dans la prise en charge du cancer de la vessie et le développement clinique, soutiendra l'avancement de NDV-01, le traitement de la société pour le cancer de la vessie non invasif au muscle (NMIBC).
Cette nomination intervient alors que Relmada se prépare à lancer un essai de phase 3 pour NDV-01 au premier semestre 2026, suite aux données positives de la phase 2 présentées lors de l'AUA 2025. La formulation prête à l'emploi à libération prolongée de NDV-01 vise à améliorer le traitement actuel combinant gemcitabine/docétaxel en offrant une administration plus facile en dehors des établissements hospitaliers.
Relmada Therapeutics (NASDAQ:RLMD) hat den renommierten urologischen Onkologen Dr. Yair Lotan zum Vorsitzenden seines Clinical Advisory Board (CAB) ernannt. Dr. Lotan, mit über 20 Jahren Erfahrung in der Behandlung von Blasenkrebs und klinischer Entwicklung, wird die Weiterentwicklung von NDV-01 unterstützen, der Behandlung des Unternehmens für nicht-muskelinvasiven Blasenkrebs (NMIBC).
Die Ernennung erfolgt, während Relmada sich darauf vorbereitet, im ersten Halbjahr 2026 eine Phase-3-Studie für NDV-01 zu starten, nach positiven Phase-2-Daten, die auf der AUA 2025 vorgestellt wurden. Die gebrauchsfertige, langwirksame Formulierung von NDV-01 zielt darauf ab, die derzeitige Kombinationstherapie mit Gemcitabin/Docetaxel zu verbessern, indem sie eine einfachere Verabreichung außerhalb von Krankenhauseinrichtungen ermöglicht.
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- Phase 3 trial not starting until H1 2026, indicating a lengthy timeline to potential commercialization
Insights
Relmada's NDV-01 bladder cancer program gains credibility with renowned expert Dr. Lotan joining as Phase 3 approaches in 2026.
Relmada's appointment of Dr. Yair Lotan as Clinical Advisory Board Chair represents a strategic strengthening of their bladder cancer program as they prepare for Phase 3 trials of NDV-01. Dr. Lotan brings over 20 years of specialized experience in bladder cancer treatment and biomarker research, positioning him ideally to guide this critical development stage.
The timing is particularly significant as NDV-01 advances toward Phase 3 trials in H1 2026 following what the company describes as positive Phase 2 data presented at AUA 2025. NDV-01 addresses non-muscle invasive bladder cancer (NMIBC), where current treatment options have limitations.
What makes NDV-01 potentially valuable is its formulation advantage. The current standard gemcitabine/docetaxel combination requires complex hospital preparation, while NDV-01 offers a ready-to-use sustained release formulation that could enable wider adoption in outpatient settings. This could represent a meaningful improvement in treatment accessibility if clinical efficacy is confirmed in Phase 3.
Dr. Lotan's expertise in establishing treatment guidelines and health economics research suggests Relmada is positioning strategically not just for clinical success but also for eventual market adoption and reimbursement considerations. This appointment enhances Relmada's scientific credibility and provides valuable clinical development guidance as they approach the crucial Phase 3 stage for NDV-01.
Dr. Lotan’s distinguished expertise in bladder cancer care and clinical development brings further scientific acumen to Relmada’s NDV-01 program
Phase 3 trial for NDV-01 expected to begin in H1 2026
CORAL GABLES, Fla., July 15, 2025 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system indications, today announced the appointment of Yair Lotan, MD, a distinguished urologic oncologist, as Chair of Relmada’s Clinical Advisory Board (CAB). Dr. Lotan’s deep expertise in bladder cancer care and clinical research will be invaluable as Relmada prepares to initiate a Phase 3 trial for NDV-01 in H1 2026, building on positive Phase 2 data, presented at the American Urology Association 2025 Annual Meeting (AUA 2025) on April 28, 2025.
Dr. Lotan brings more than two decades of experience in bladder cancer care, clinical development and academic medicine. As a nationally recognized expert in molecular biomarkers, with involvement in the establishment of practice guidelines for the management of bladder cancers and health economics research, Dr. Lotan is well suited to Chair Relmada’s Clinical Advisory Board and to help shape the clinical development strategy for NDV-01.
“We believe that Yair’s first-hand understanding of the current treatment challenges in bladder cancer, combined with his deep clinical development expertise, will help to strengthen and enrich the clinical development program for NDV-01,” said Sergio Traversa, Chief Executive Officer, Relmada. “As we prepare to advance NDV-01 to Phase 3 studies, we are confident that Yair’s leadership of our Clinical Advisory Board and his prominent role in the bladder cancer community will help to position the program for success.”
Raj Pruthi, MD, Chief Medical Officer-Urology, Relmada noted, “In my experience, a Clinical Advisory Board can play a vital role in the progression of an innovative product candidate, providing scientific insights and strategic advice. Relmada’s goal is to bring NDV-01 to patients with non-muscle invasive bladder cancer (NMIBC) as soon as possible. We are very pleased to have Yair on board to Chair Relmada’s Clinical Advisory Board. His influential thought-leadership will help Relmada to optimize our product development plan for NDV-01.”
“In my view, impressive initial Phase 2 data presented at AUA 2025 solidly support NDV-01’s unique potential to become a class-leading, bladder-sparing therapy for the treatment of NMIBC,” commented Dr. Lotan, CAB Chair, Relmada. “While the combination of gemcitabine/docetaxel (Gem/Doce) has been embraced by the medical community, it is difficult to formulate the combination outside of a hospital setting. NDV-01’s simple, ready-to-use sustained release formulation could enable wider patient adoption and transform the care of NMIBC. I am excited to Chair the Clinical Advisory Board at this pivotal time for Relmada.”
About Yair Lotan, MD
Yair Lotan, MD, is a urologic oncologist with over 20 years of experience caring for bladder cancer patients.
Dr. Lotan graduated with high honors from the University of Texas at Austin and with honors from Baylor College of Medicine in Houston. He trained in general surgery and urology at UT Southwestern Medical Center in Dallas. Dr. Lotan heads a clinical research office and is involved in many clinical trials related to bladder cancer.
Dr. Lotan is known nationally for his research on urine markers and molecular markers, which will help determine which patients are at higher risk for recurrent cancer. He is also involved in health economics research, which evaluates the cost-effectiveness of surgery and cancer prevention. Dr. Lotan has participated in multiple collaborative studies involving early detection of bladder cancer. He is also a co-investigator on several NIH funded trials evaluating urine-based tumor markers. Dr. Lotan is the primary investigator on several investigator-initiated studies evaluating the role of urine and tissue markers in the management of bladder cancer. He is a member of panels that establish guidelines for the evaluation of hematuria and management of muscle invasive bladder cancer. Dr. Lotan has published over 650 peer reviewed papers and multiple reviews and book chapters.
Dr. Lotan is a frequent guest speaker at medical conferences around the world and belongs to numerous professional organizations, including the American Urological Association, the Society of Urologic Oncology, and the Bladder Cancer Advocacy Network. He also serves as editorial reviewer for medical periodicals such as the Journal of Urology, European Urology, Cancer, Urologic Oncology, and the British Journal of Urology International.
Dr. Lotan has been included in D Magazine’s Best Doctors list multiple times over the last decade.
About NDV-01
NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for the treatment of bladder cancer. It is designed to enable Gem/Doce bladder retention and gradual drug release over 10 days. The formulation creates a soft matrix that enhances local exposure while minimizing systemic toxicity. NDV-01 is designed to be administered in-office, in less than 10 minutes, and does not require anesthesia or specialized equipment. It is protected by patents through 2038.
About NMIBC
NMIBC represents ~
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for oncology-related and central nervous system conditions. Its lead candidates, NDV-01 and sepranolone, are advancing through mid-stage clinical development with the potential to address significant unmet needs.
For more information, visit www.relmada.com
Forward-Looking Statements:
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as “if”, “may”, “expects”, “anticipates”, “believes”, “will”, “will likely result”, “will continue”, “plans to”, “potential”, “promising”, and similar expressions. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including potential for Relmada’s product candidates to progress, including the potential for Phase 2 NDV-01 data to continue to deliver positive results supporting further development, potential for clinical trials to deliver statistically and/or clinically significant evidence of efficacy and/or safety, failure of top-line results to accurately reflect the complete results of the trial, failure of planned or ongoing preclinical and clinical studies to demonstrate expected results, potential failure to secure FDA agreement on the regulatory path for NDV-01, and sepranolone, or that future NDV-01, or sepranolone, clinical results will be acceptable to the FDA, failure to secure adequate NDV-10, or sepranolone, drug supply, and the other risk factors described under the heading “Risk Factors” set forth in the Company’s reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.
Investor Contact:
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com
Media Inquiries:
Corporate Communications
media@relmada.com
FAQ
Who is Dr. Yair Lotan and what is his new role at Relmada Therapeutics (RLMD)?
What is NDV-01 and how does it differ from current bladder cancer treatments?
When will Relmada Therapeutics (RLMD) begin Phase 3 trials for NDV-01?
What were the results of NDV-01's Phase 2 trials presented at AUA 2025?
What type of cancer does Relmada's NDV-01 target?
